BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CHEMISTRY CALIBRATOR (CHEM CAL)

    MDR report key: 6142395 · Received December 2, 2016

    Report

    Report Number
    2432235-2016-00746
    Event Type
    Malfunction
    Date Received
    December 2, 2016
    Date of Event
    November 7, 2016
    Report Date
    May 23, 2017
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS INC.
    Product Code
    JIX
    PMA / PMN Number
    K050374
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INITIAL MDR 2432235-2016-00746 WAS FILED ON (B)(6) 2016. CORRECTED INFORMATION ((B)(6) 2017): UPON FURTHER REVIEW IT WAS NOTED THAT THE INITIAL MDR 2432235-2016-00746 FILED ON (B)(6) 2016 HAD THE INCORRECT MANUFACTURING SITE/ADDRESS LISTED IN SECTION .

    Additional Manufacturer Narrative · 1

    A SIEMENS TECHNICAL APPLICATION SPECIALIST DETERMINED THAT THE CUSTOMER WAS USING INCORRECT CALIBRATION FACTOR VALUE FOR GLUCOSE METHODS. UPON SIEMENS TAS INSTRUCTIONS, THE CUSTOMER CORRECTED THE CALIBRATION FACTOR VALUE. THE CAUSE OF THE INCORRECT CALIBRATION FACTOR VALUE BEING USED WAS DUE TO THE HUMAN FACTOR ISSUE. THE DEVICE IS PERFORMING AS INTENDED. NO FURTHER EVALUATION OF DEVICE IS NEEDED.

    Description of Event or Problem · 1

    THE CUSTOMER OF THE ADVIA CHEMISTRY INSTRUMENTS WAS USING INCORRECT CALIBRATION FACTOR VALUE FOR ALL GLUCOSE METHODS ON ALL FOUR OF THEIR INSTRUMENTS. AS PER ADVIA CHEMISTRY CALIBRATOR INSTRUCTIONS FOR USE, GLUCOSE CALIBRATION VALUE CHANGES EVERY SIX MONTHS. THE CUSTOMER HAD RUN PATIENT SAMPLES WITH INCORRECT CALIBRATION FACTOR VALUES. THE CUSTOMER REPORTED THE RESULTS WITH INCORRECT CALIBRATION FACTOR VALUES TO THE PHYSICIAN(S). THE CUSTOMER DID NOT REPEAT ANY OF THE PATIENT SAMPLES TO VERIFY THE RESULTS. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE USE OF INCORRECT CALIBRATION VALUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    794017 CHEMISTRY CALIBRATOR (CHEM CAL) CHEMISTRY CALIBRATOR (CHEM CAL) JIX SIEMENS HEALTHCARE DIAGNOSTICS INC. CHEMISTRY CALIBRATOR (CHEM CAL) 680726

    Patients

    Seq Age Sex Outcome Treatment
    1